Lifestyle Intervention in Type 2 Diabetes
WeightPump
Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial
1 other identifier
interventional
54
1 country
6
Brief Summary
The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedStudy Start
First participant enrolled
October 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedMarch 19, 2021
March 1, 2021
4.3 years
June 1, 2016
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight change
The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.
6 months
Secondary Outcomes (5)
Glycemic control
6 months
Body composition
6 months
Diabetes Treatment Satisfaction
6 months
Intermediate weight change
3 months
Retention of weight change
1 year
Study Arms (2)
Diet and physical activity program
EXPERIMENTALDiet and physical activity program with individual coaching
control
NO INTERVENTIONstandard care
Interventions
A personalized intervention focused on improving diet and increasing physical activity will be implemented at-home with a monthly support by a registered dietician and physical activity educator during 6 months
Eligibility Criteria
You may qualify if:
- Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy.
- Patients addressed for the insulin pump follow-up to the home care provider supporting the study.
- Public health care security affiliation.
You may not qualify if:
- Breastfeeding or pregnant woman.
- Not willing to participate as assessed by the investigator.
- Patients unable to ride a training bike.
- Unavailable in the next 6 months.
- Patient without a medical certificate done in the last 12 months by a cardiologist attesting the ability to participate in a physical activity reinforcement program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icadomlead
- AGIR à Domcollaborator
Study Sites (6)
Annecy-Genevois Hospital
Annecy, 74370, France
Pierre Oudot Hospital
Bourgoin, 38302, France
Métropole Savoie Hospital
Chambéry, 73000, France
Alpes Léman Hospital
Contamine-sur-Arve, 74130, France
Grenoble University Hospital
Grenoble, 38043, France
Marseille European Hospital
Marseille, 13003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Laure Borel, MD PhD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 6, 2016
Study Start
October 4, 2016
Primary Completion
January 19, 2021
Study Completion
March 17, 2021
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share